HomeUSAAXELGAARD MFG. CO., LTD.

AXELGAARD MFG. CO., LTD.

USA · Fallbrook
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Israel — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 5 registration records and 11 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States5 registration records, 11 510(k), 0 PMA
Brazil0 confirmed, 2 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: AXELGAARD MFG. CO., LTD.

Company information

Country
USA
City
Fallbrook

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

11985
11987
11988
11997
11998
22000
12002
12008
12013
12014

FDA listed device types

Electrode, Cutaneous 1Device, Iontophoresis, Other Uses 1Electrode, Electrocardiograph 1

Registration details (sample)

MarketIdentifierNameClass / date
USK132422PALS PLATINUM NEUROSTIMULATION ELECTRODES2014-02-13
USK130987VALUTRODE NEUROSTIMLATION ELECTRODES2013-07-17
USK080580COMFORT IONTOPHORESIS ELECTRODES/ BUFFERED IONTOPHORESIS ELECTRODE TREATMENT, MODEL SMALL DDS275, MEDIUM DDM325, LARGE D2008-06-18

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